Similar safety and efficacy in previously treated adults with growth hormone deficiency randomized to once-weekly somapacitan or daily growth hormone.

ABSTRACT:

Objective

Somapacitan is a long-acting, reversible albumin-binding growth hormone (GH) derivative in development. This study aimed to evaluate the safety and efficacy of once-weekly somapacitan versus daily GH over 52 weeks in Japanese patients with adult growth hormone deficiency (AGHD).

Design

Phase 3, multicentre, randomized, parallel-group, open-label, active-controlled trial (NCT03075644).

Patients

Previously GH-treated Japanese patients with AGHD were randomized 3:1 to somapacitan (n = 46) or daily GH (n = 16) for 20 weeks' dose titration and 32 weeks' fixed-dose treatment.

Measurements

Primary endpoint was the incidence of adverse events (AEs). Secondary endpoints included change from baseline to week 52 in visceral, subcutaneous and total adipose tissue

SUBMITTER: Otsuka F 

PROVIDER: S-EPMC7689735 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature